Accuracy of Blood Glucose Detection by Diabetes Alert Dogs

Type I Diabetes Mellitus Clinical Trial

Official title:

Accuracy of Blood Glucose Detection by Diabetes Alert Dogs

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02126605
• Other study ID #: 17296
• Status: Not yet recruiting
• Phase: N/A
• First received: April 24, 2014
• Last updated: April 28, 2014
• Start date: July 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2014
• Source: University of Virginia
• Contact: Jesse Grabman, B.A.
• Phone: 434-924-5316
• Email: JHG5DQ[@]hscmail.mcc.virginia.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Even though there is growing interest in and use of trained Diabetes Alert Dogs (DADs) as a way to monitor blood glucose in type 1 diabetes (T1D), no scientific studies have confirmed the ability of DADs to accurately detect extreme high and low blood sugar. The current project is the first preliminary investigation into the accuracy of DADs, using scientifically rigorous research methods similar to those required to demonstrate accuracy in blood glucose meters. The primary aim of the project is to test the hypotheses that DADs are accurate at detecting extreme blood sugar levels in adults and children with T1D. The proposed project has several other secondary aims, which include determining: 1) the glycemic thresholds and time course for hypo- and hyperglycemic DAD alerts, 2) the degree to which alert accuracy is consistent across different DADs, and 3) whether or not DAD owners appear to experience better psychosocial status and quality of life compared to other individuals with T1D.

Description:

In the proposed project, DAD alerts will be compared to blood glucose (BG) readings from a continuous glucose monitoring (CGM) device, as well as a BG meter. CGM, BG meter, and DAD alert data will be collected over a 4-wk period. CGM devices will be "blinded" so that BG readings will not be shown. This will allow for a direct comparison between objective glucose readings generated by approved BG monitoring devices and DAD alerts. This study will also utilize two methods for measuring DAD alerts: (1) use of the event recorder mechanism of the CGM device, and (2) collection of more detailed and qualitative data on DAD alerts using diaries (Daily DAD Diaries) to collect information concerning the occurrence, timing, and type of DAD alerts.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 65 Years

Eligibility

Inclusion Criteria:

• The participant must have had type 1 diabetes for at least 1 year and been taking insulin since diagnosis

• The participant must have a DAD placed in their home for a minimum of 6 months.

• Participants must not currently be using a continuous glucose monitor (CGM) in their diabetes management.

• Participants must be capable of performing all tasks involved in the study protocol, including filling out questionnaires and diaries in English.

• Participants must have an internet-connected computer compatible with study software.

• Willingness to avoid consumption of acetaminophen-containing products for the duration of the study.

Exclusion Criteria:

• Pregnant women-self reported

• Current use of a CGM

• History of a systemic deep tissue infection with methicillin-resistant staph aureus or Candida albicans

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type I Diabetes Mellitus

Locations

Country	Name	City	State
United States	University of Virginia Center for Behavioral Medicine Research	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent agreement between DAD alerts and glucose readings		5 weeks	No
Secondary	Psychosocial variables (quality of life, fear of hypo-/hyperglycemia, diabetes distress, self-efficacy, and DAD experiences)		Baseline, 5 weeks	No